Halozyme reports results from clinical study of ENHANZE

Halozyme Therapeutics announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE drug delivery technology, in approximately 30 seconds. In the study, the biologic was delivered with Halozyme’s proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated. In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers. The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme’s ENHANZE and HVAI technologies. Data Highlights include: 96% of participants stated that they would be willing to receive the injection again; 90% of participants indicated feeling either no pain or mild pain immediately after injection; and Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less.